Document process-related residual protein in final drug substance

31 January 2019

Standard analyses do not detect trace amounts of protein process additives, otherwise known as residual proteins. Examples include growth factors, Benzonase nuclease, Protein A, enzymes for site-specific PEGylation, etc.

Instead you can now use a customized LC-MS assay. It will detect protein residuals of interest – in both your final drug substance and process samples.

Advantages include

  • Low-to-sub ppm detection.
  • ID and quantification of key residuals.

You can use the results for

  • FDA/EMA documentation of process-related residual impurities in final drug substance.
  • Evaluation of clearance throughout purification steps.
  • Process validation and establishment of batch acceptance criteria.

Alphalyse offers analysis development for your residual of interest, and analysis of both final drug substance and process samples. Above all, we perform low-to-sub ppm detection along with identification and quantification of key residual proteins.

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